To whom is this relevant?
People with Parkinson’s whose symptoms have become quite disagreeable regarding “Off” time. The main criteria are straightforward. You must be at least 30 years of age, be judged by the investigator to be inadequately controlled by your medication, have obvious “Off” and “On” states and have a minimum of 2.5 hours of “Off” time per day. This is one of the few trials that do not exclude those who have had the DBS procedure.
We understand that the recruitment target has been met, so this Trial is closed to additional participants. This has happened very quickly by the standards set by other trials, and possibly demonstrates the pent-up demand for more user-friendly treatments for later stage PwPs.
What is being trialled and where?
This research at Derriford Hospital in Plymouth is part of an international series of Clinical trials of the compound ABBV-951 (aka the drug Foslevodopa), which is delivered (infused) in liquid form under the skin.
This is a Phase 3 study to evaluate the safety and tolerability of continuous subcutaneous infusion. This technique infuses fluids under the skin through a fine needle inserted into the abdomen, the back or a thigh or an arm. From the available evidence it is effective with minimal complications. The advantages over intravenous infusion include ease of use and the lack of potential serious complications, particularly infections.
What is involved?
This a 52-Week trial requiring 6 visits to Derriford. Everyone in the trial knows what they are taking and all participants have the same treatment regime (it is open-label, single-arm). The infusion device is “minimally invasive”. For those unfamiliar with infusion, the pump specified for this trial is the Chrono Par ambulatory infusion pump from Cané.
Interested in taking part?
Recruitment begins early in the New Year. Patient Participant leaflets are not yet available.